Manufacturing Engineer II

ESSENTIAL FUNCTIONS AND BASIC DUTIES

(Other duties may be assigned)

• Follow employee guidelines and quality system regulations as defined by Nissha Medical Technologies practices, policies and standard operating procedures to ensure that customer requirements and industry standards and or regulations are met.
• Demonstrate knowledge and act in accordance with NMT’s employee guidelines and applicable quality standards as outlined in NMT’s quality manual.
• Abide by all safety and security rules set forth by the company and regulatory agencies.
• Regular attendance is required.

• Provide engineering support to manufacturing operations on a routine basis.
• Address product related issues arising on the production floor.
• Investigate non‑conforming materials and products from receiving inspection and the production floor.
• Initiate and own CAPAs as necessary.
• Support supplier quality issues and changes in conjunction with the buyer.

• Provide the customer with a dedicated SME for their product line.
• Implement changes required by the customer and request changes to their production lines as needed.
• Investigate customer complaints with quality when necessary.

• Continually improve manufacturing methods, systems and processes to optimize product performance and reduce manufacturing costs.
• Identify and evaluate opportunities for improvement and make specific recommendations for adoption.
• Perform cost analyses to reduce or optimize product costs.

• Support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost‑effective products with optimized yields.
• Ensure compliance with GMPs and internal protocols.
• Use appropriate statistical support and design of experiments (DOE) when developing recommendations.

• Determine specific requirements of manufacturing operations in order to specify equipment, fixturing, and process parameters.
• Collaborate on design with suppliers to fulfill equipment and fixturing requirements.

• Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Apply appropriate statistical methodologies.

• Define and generate all required documentation in support of manufacturing products and processes. These include ECOs, engineering protocols, FMEAs, reports, manufacturing instructions and procedures.
• Maintain a high level of documentation that is clear and understandable, contains pertinent and accurate information, and will promote confidence with customers and auditors.

• Bachelor's Degree in Engineering.
• A minimum of 3 years of experience in a manufacturing or production environment.
• Solid interpersonal and communication skills and ability to work in a team environment.
• Experience with CAPAs, MRBs, and/or NCMRs.
• Experience with statistical analysis of production processes.
• Current or recent experience with equipment and/or process qualifications and validations (IQ, OQ, PQ).
• Experience writing protocols, reports and engineering change orders.
• Advanced degree in engineering preferred.
• One year of medical device manufacturing or manufacturing in a highly regulated environment preferred.
• Experience with quality standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 11 preferred.
• Experience designing and conducting DOEs using Mini Tab preferred.

The established compensation range for this position will be $70,000 to $80,000 per year (paid on a bi‑weekly basis) based on experience and qualifications.

Great benefits available including medical, dental, vision, 401(k), short‑term disability, long‑term disability, basic and voluntary life insurance, paid vacation time, paid sick leave, educational assistance, and more!

Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.

If you need assistance with completing the online application process, please call (719) 426‑9074.